Puolakka Kari, Kautiainen Hannu, Möttönen Timo, Hannonen Pekka, Korpela Markku, Julkunen Heikki, Luukkainen Reijo, Vuori Kaisa, Paimela Leena, Blåfield Harri, Hakala Markku, Leirisalo-Repo Marjatta
Lappeenranta Central Hospital, Lappeenranta, Finland.
Arthritis Rheum. 2004 Jan;50(1):55-62. doi: 10.1002/art.11436.
To compare the efficacy of therapy with a combination of disease-modifying antirheumatic drugs (DMARDs) versus therapy with a single DMARD in the prevention of work disability in patients with early rheumatoid arthritis (RA).
In the Finnish Rheumatoid Arthritis Combination Therapy trial, 195 patients with recent-onset RA were randomly assigned to receive either combination therapy with DMARDs (sulfasalazine, methotrexate, hydroxychloroquine) plus prednisolone or single therapy with a DMARD with or without prednisolone. After 2 years, the drug treatment strategy was no longer restricted. At baseline, 162 patients (80 in the combination-treatment group and 82 in the single-treatment group) were still working or at least available for work. After 5 years of followup, data on all sick leave and retirement were obtained from social insurance registers or case records. The main outcome for each patient was the cumulative duration of all sick leaves and RA-related disability pensions, divided by the observation period during which the patient was not retired because of another disease or because of age.
The cumulative duration of work disability per patient-observation year was significantly lower in those randomized to combination therapy than in those randomized to single therapy: median 12.4 days (interquartile range [IQR] 0-54) versus 32.2 days (IQR 6-293) (P = 0.008, sex- and age-adjusted P = 0.009). This was mainly due to the difference in sick leaves (i.e., work disability periods </=300 days): median 11.7 days (IQR 0-44) per patient-observation year in those treated with combination therapy and 30.0 days (IQR 6-68) in those treated with single therapy (P = 0.002). No statistically significant difference was seen in RA-related disability pensions.
Aggressive initial treatment of RA with a combination of DMARDs improves 5-year outcome in terms of lost productivity in patients with RA of recent onset.
比较使用改善病情抗风湿药物(DMARDs)联合治疗与单一DMARD治疗对早期类风湿关节炎(RA)患者预防工作能力丧失的疗效。
在芬兰类风湿关节炎联合治疗试验中,195例近期发病的RA患者被随机分配接受DMARDs(柳氮磺胺吡啶、甲氨蝶呤、羟氯喹)联合泼尼松龙治疗或单一DMARD联合或不联合泼尼松龙治疗。2年后,药物治疗策略不再受限。基线时,162例患者(联合治疗组80例,单一治疗组82例)仍在工作或至少可从事工作。随访5年后,从社会保险登记处或病例记录中获取所有病假和退休数据。每位患者的主要结局是所有病假和RA相关残疾抚恤金的累计时长,除以患者因其他疾病或年龄未退休的观察期。
随机接受联合治疗的患者每患者-观察年的工作能力丧失累计时长显著低于随机接受单一治疗的患者:中位数为12.4天(四分位间距[IQR]0 - 54),而单一治疗组为32.2天(IQR 6 - 293)(P = 0.008,经性别和年龄调整后P = 0.009)。这主要是由于病假时长的差异(即工作能力丧失期≤300天):联合治疗组患者每患者-观察年的中位数为11.7天(IQR 0 - 44),单一治疗组为30.0天(IQR 6 - 68)(P = 0.002)。在RA相关残疾抚恤金方面未观察到统计学显著差异。
对近期发病的RA患者采用DMARDs联合进行积极的初始治疗,在5年结局方面可改善患者的生产力损失情况。